Core noun
Failure mode assignments
Deterministic labels derived from preserved recall-reason text.
Indexed record set
89,789 assignments
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- Mode
- Device software or design
- Product
- BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- BD Pyxis MedStation ES 7 Drawer Auxiliary Tower, REF: 324
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
-
- Mode
- Device software or design
- Product
- BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- Restore Clinician Programmer Application Software, model number A71100, used with the Restore Neurostimulators.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- issue with some legacy clinician programmer software
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- Mode
- Device software or design
- Product
- Automated Impella Controller (AIC), Product No. 0042-0000-US, 0042-0010-US, 0042-0040-US. Used with Impella Ventricular Support Systems (cardiovascular)
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software Update Available. The update resolved an issue
-
- Mode
- Device software or design
- Product
- Baxter TruSystem 7500 Hybrid (SC), Product Code 1854086
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- AggreGuide A-100 Instrument
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software design issue
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- Mode
- Device software or design
- Product
- Baxter Stationary column TruSystem 7500, Product Code 1717020
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, clinical chemistry analyzer that runs tests on serum, plasma, urine, or cerebral spinal fluid in random access and batch modes. Tests performed using this system are intended for in vitro diagnostic use.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software Versions (V1.4 SMN 11314625 and V1.4 China SMN 11316885) may
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- Mode
- Device software or design
- Product
- Automated Impella Controller (AIC), product number 0042-000-US with software versions V8.4 and V8.4.1.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
-
- Mode
- Device software or design
- Product
- BD Pyxis: MedStation ES, REF: 323; Anesthesia Station ES, REF: 327; MedStation ES Tower, REF: 352;
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software, and Windows 10 operating system may experience the application randomly hang, freeze and/or crash, which may result in
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- Mode
- Device software or design
- Product
- BD Alaris System Manager REF: 9601, compatible with BD Alaris PC Units
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
-
- Mode
- Device software or design
- Product
- Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software anomaly
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- Mode
- Device software or design
- Product
- Brand Name: VITROS Product Name: VITROS 3600 Immunodiagnostic System Model/Catalog Number: 6802783 (New), 6802914 (Certified/Refurbished), 6904000 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: no, not a component
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software versions 3.8.0 may
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- Mode
- Device software or design
- Product
- Brand Name: VITROS Product Name: VITROS XT 7600 Integrated System Model/Catalog Number: 6844461 (New), 6272222 (Certified), 6904003 (China) Software Version: version 3.8.0 or higher Product Description: In vitro diagnostic chemistry analyzer. FDA 3 letter product code: JJE Component: No, not a component
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software versions 3.8.0 may
-
- Mode
- Device software or design
- Product
- BIOMERIEUX VIDAS 3, Compact immunoanalyzer with full traceability and automation
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- incorrect update of the calibration status by the software
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- Mode
- Device software or design
- Product
- ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1 SE), 8300-0169 (Abacus V3.1 ME), 8300-0191 (Abacus V3.2 CE), 8300-0192 (Abacus V3.2 SE), 8300-0193 (Abacus V3.2 ME), 8300-3391 (Abacus V3.3 CE), 8300-3392 (Abacus V3.3 SE), and 8300-3393 (Abacus V3.3 ME). Commonly used with ExactaMix automated compounding devices (ExactaMix 1200 and ExactaMix 2400).
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- error when using specific Abacus Order Entry & Calculation software
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- Mode
- Device software or design
- Product
- Dose IQ Safety Software used with Spectrum IQ Infusion Pump
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software issue: The defect
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- Mode
- Device software or design
- Product
- Azurion systems with software release R2.0.x
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software defect
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- Mode
- Device software or design
- Product
- Alinity m System, Part No. 08N53-002
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- issue with the installation of updated camera firmware
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- Mode
- Device software or design
- Product
- Baxter Spectrum Wireless Battery Modules A/B/G/N, product code 35223, used with either of the following: 35700BAX2 (Spectrum V8 infusion pump) or 3570009 (Spectrum IQ infusion pump) Baxter SIGMA Spectrum V8 Infusion Pump
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software issue
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- Mode
- Device software or design
- Product
- AtomLab 500Plus Dose CalibratorSoftware 2.0.00 through Revision 2.0.08, inclusive Model: 086-332
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may
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- Mode
- Device software or design
- Product
- Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Material Number (SMN): 11066000 - Product Usage: intended for the qualitative and quantitative analysis of various body fluids, using photometric, turbidimetric, chemiluminescent, and integrated ion selective electrode technology for clinical use.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- Software v1.23.2 and lower-may
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- Mode
- Device software or design
- Product
- Atomlab 500 Dose Calibrator Software 2.0.00 through Revision 2.0.08, inclusive Model: 086-330.
- Rule
reason.device_software_design· v1.0.0- Evidence excerpt
- software deletes the isotope, but not the associated dial setting. Possible other stored custom isotopes may